AVID Medical Recalls Biopsy Kits Due to Sterility Concerns
AVID Medical is recalling 340 biopsy kits because they contain sodium chloride ampules subject to a separate recall for quality and sterility issues.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly identifies the agency classification as Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never be below 4.
Plain-English summary
AVID Medical, Inc. is recalling 340 kits of Haylard UNIV IMAGING BIOPSY TRUCUSTOM (Model/Item Number: VARV042-03). The recall is due to potential product quality and sterility issues associated with the sodium chloride ampules included in these kits.
The sodium chloride ampules are subject to a separate recall by Spectra Medical. The affected kits were distributed domestically in Illinois, North Carolina, Virginia, and Wyoming. Specific kit lots include 1668365, 1668366, 1688166, 1692637, and 1696930, while the recalled sodium chloride ampule lots are AB5002 and AB4003.
Healthcare facilities and consumers should stop using these kits immediately and contact AVID Medical, Inc. for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Biopsy Kits
- Hazard
- Affected units
- 340
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Model/Item Number (Kit): VARV042-03
- UDI-DI: 10809160490822
- Kit Lots: 1668365
- 1668366
- 1688166
- 1692637
- 1696930
- Recalled Sodium Chloride Ampule Lot: AB5002
- AB4003
Distribution
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